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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks at the Medical Countermeasures Review Roll Out

Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Medical Countermeasures Review Roll Out
August 19, 2010

It’s a real pleasure for me to be here this morning. As some of you know, I have been working on issues of biosecurity and public health preparedness for many years, and it is very exciting to see this degree of commitment, collaboration and progress in a field so important to the health of our nation.

Together we can—and will—build a safer America.

We are all here today because we are committed to doing more … and we must. We live in a rapidly transforming world, and biological, chemical, radiological and nuclear threats pose a unique and growing challenge. Developing and evaluating medical products to protect against these threats is a complex, time-urgent requirement.

That’s why the FDA has participated closely and actively in this Department-led review.

And because FDA evaluation of product safety and efficacy so significantly impacts the course of product development, as the Secretary indicated, the review identified our agency as fundamental to the success of the Enterprise. Already, the FDA conducts activities to increase access to and availability of safe, effective medical countermeasures.

This initiative will allow us take our actions to the next level. We have developed an FDA Action Plan that, once implemented, will allow our agency to do its part in helping strengthen and transform the medical countermeasure enterprise, and this will have even broader applications. Specifically, the plan has been designed to address in three major ways some of the key challenges we face as an agency—and as a nation—in the development and availability of medical countermeasures.

First, FDA will support enhanced review and novel manufacturing approaches for the highest priority MCMs. We will work with developers and government partners from very early in the development process—and in a highly interactive manner—to define viable regulatory pathways, speeding progress toward product approval by helping to anticipate and resolve bottlenecks, and to identify and address scientific problems that may emerge.

Second, FDA will advance regulatory science and improve countermeasure development and evaluation pathways by strengthening our own scientific capacity and building collaborations with government and academia. This emerging science will support the development of tools and standards to assess the safety, efficacy and quality of new medical products. This initiative will allow FDA to identify and help solve the scientific challenges that hinder medical countermeasure development and, without solutions, result in unacceptably long delays in getting the products we need.

Third and finally, we will work with HHS and other government partners to conduct an examination of the legal framework, as well as regulatory and policy approaches, toward MCM development and availability, to assess adequacy, or improvements needed, to properly support preparedness and response.

Ultimately, our mission at FDA is to do everything we can today to ensure the safety, effectiveness and availability of medical countermeasures tomorrow. We cannot afford to wait until an emergency to discover that a product is too risky or doesn’t work. And we must do our part to expedite the development of promising products—and identify those that won’t make the cut as early as possible in this process. 

I’d like to close by thanking everyone at the FDA who has worked so hard throughout this review to maximize our agency’s contribution to the effort; all of the partners and friends with whom we’ve collaborated along the way; and, finally, Secretary Sebelius and Dr. Lurie for their excellent leadership and unwavering dedication to an issue of critical importance to our country.

Congratulations to everyone for their hard work—and good luck to us all on the hard work that lies ahead.

Thank you.